Scientist III - Analytical Chemist (Drug Substance Analysis) - FSP

Parexel International; Rahway (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Parexel is seeking a Scientist3 - AnalyticalChemist (Drug Substance Analysis) to join our on-site team in Rahway, NJ as a full-time Parexel FSP assignment. The role focuses on stability testing and analytical method work in a GMP environment, with opportunities to contribute to process improvements.

The ideal candidate has a BS/MS in chemistry or life sciences and 3–5 years (BS) or 1–2 years (MS) of GMP lab experience, with strong chromatography, instrumentation, and documentation skills.

Qualifications

• BS/MS in Chemistry, Chemical Engineering, Biochemistry, Biology or similar life sciences and relevant GMP lab experience.
• Scientist 3 – BS with 3-5 years; MS with 1-2 years.

Responsibilities

• Perform routine and stability sample analysis in drug product stability labs.
• Draft and follow SOPs; ensure compliant documentation.
• Contribute to method development and validation activities to improve robustness.
• Support data processing, interpretation and reporting of stability data.

Skills

Chromatography

Method validation

Documentation

Communication

Teamwork

Detail-oriented

Dissolution/FtIR/KF

Education

BS/MS in Chemistry/Biochemistry or life sciences

Tools

Empower software

Job description

We are looking to fill aScientist3 -AnalyticalChemist(Drug Substance Analysis)position working asa full-time employee of Parexel FSP on long-term assignmentonsite at one of our clientslocatedinRahway, NJ.This position offers full benefits, sick time, 401K, paid holidays, and paid time off.This position does not offer any sponsorship.

Qualifications -

B.S./M.S. in Chemistry, Chemical Engineering, Biochemistry, Biology or similar life sciences and relevant years of experience as listed below in a GMP laboratory environment.

Scientist 3 - B.S. with 3-5 years of experience; M.S. with 1-2 years of experience

Required Skills and Experience

• Hands-on experience with chromatographic analysis using various UPLC, HPLC and GC techniques, including method and instrument troubleshooting
• Consistently adheres to GDP standards with accurate, compliant documentation
• General knowledge of separations science
• General understanding of analytical method development and method validation
• Hands-on experience with FTIR, KF and Dissolution
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Excellent organization to multi-task and manage multiple ongoing projects in parallel including GMP release, stability testing along with data processing, interpretation and reporting
• Ability to work independently and as part of a team, displaying self-motivation, adaptability, and a positive attitude
• Desired Skills and Experience
  • Empower software
  • Analysis of drug product and drug substance

Overview

In the drug product registration stability testing lab,you’llperform routine and stability sample analysis, SOP authoring, and day-to-day problem solving while contributing tonew technologiesand continuous improvement measures for optimized lab operations and other testing requirements.You’llapply analytical characterization technologies and compliance principles to drive method robustness and high-quality stability data supporting late-stage pharmaceutical drug product development and commercialization. The ideal candidate is proactive, collaborative, and thrives in a compliance-focused environment.

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!

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EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.